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Library > Technical Papers

505(b)(2): Fast and Cost-Effective Drug Approval

Camargo | 28-May-2012 | PDF Data sheet
As a fast and cost-effective route for drug approval, more products than ever are approved via the 505(b)(2) pathway. Camargo Pharmaceuti...

Effective Controlled Substances Supply Chain Management

DPT Labs | 23-May-2012 | PDF Data sheet
At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply...

Implementing LEAN Techniques in Quality Control

Baxter | 17-Apr-2012 | PDF Technical / white paper
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Bax...

A Clinical Perspective on IV Medication Delivery

Baxter | 09-Apr-2012 | PDF Technical / white paper
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists.  The in...

Sample Prep Proposed USP Elemental Impurities

SGS | 27-Feb-2012 | PDF Technical / white paper
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how s...

How to Approach Identification of Anomalous Peaks

SGS | 22-Feb-2012 | PDF Technical / white paper
The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and...

The Scientific Path to Cycle Development

Baxter | 20-Feb-2012 | PDF Technical / white paper
To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing...

Overcoming the Challenges of Clinical Trial Supply Distribution

Almac Group | 15-Feb-2012 | PDF Data sheet
The distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinica...

Ensuring Quality & Regulatory Compliance w/ Service Providers

DPT Labs | 25-Jan-2012 | PDF Data sheet
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than...

New Challenges in Early Clinical Development

SGS | 24-Jan-2012 | PDF Technical / white paper
With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where th...

Risk-Reducing Solutions for Global Study Logistics

World Courier | 01-Jan-2012 | PDF Technical / white paper
Dr. Rüdiger Lomb, Global Director, Quality & Technical Compliance for World Courier, discusses the merits of using a fully-integrated...

Glycosylation of Proteins: Structure & Analysis

SGS | 06-Dec-2011 | PDF Technical / white paper
Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glyc...

Crystallization – Understanding and developing the process

Solvias AG | 28-Nov-2011 | PDF Technical / white paper
In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intima...

Application of a partner-driven approach in winning and maintaining outsourced pharmaceutical business

Alkermes | 17-Nov-2011 | PDF Case study
Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for t...

Characterisation of Biopharmaceutical Proteins

14-Nov-2011 | PDF Technical / white paper
Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market...

Improving Signal Detection in Drug Safety

SGS | 07-Nov-2011 | PDF Technical / white paper
Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture syste...

Using the Four Pillars to Support Data-Driven Feasibility Success

INC Research | 03-Nov-2011 | PDF Technical / white paper
Download our latest Foresight articleThe challenges of clinical trial recruitment are well-known to drug developers. Yet while difficulti...

Securing the Supply Chain: Third-Party Contingency Planning for Clinical Trial Transport

World Courier | 01-Nov-2011 | PDF Technical / white paper
WORLD COURIER is widely recognized as the largest and most experienced specialty courier service with a network of 150 company-owned GxP-...

Container Testing: Quantifying Metal Contaminants

SGS | 18-Oct-2011 | PDF Technical / white paper
Regulatory Agencies have clearly established the need to identify and control harmful chemicals which may leach from container closure sy...

Camargo: Paws-Down, Your 505(b)(2) Experts

Camargo | 17-Oct-2011 | PDF Data sheet
The 505(b)(2) pathway can lead to approval for new drugs in a fraction of the time and cost required by traditional paths; but special re...

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